CN106794307A - Medicament injection apparatus with the resetting-mechanism for allowing piston rod to retract when cartridge case is changed - Google Patents

Medicament injection apparatus with the resetting-mechanism for allowing piston rod to retract when cartridge case is changed Download PDF

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Publication number
CN106794307A
CN106794307A CN201580054519.0A CN201580054519A CN106794307A CN 106794307 A CN106794307 A CN 106794307A CN 201580054519 A CN201580054519 A CN 201580054519A CN 106794307 A CN106794307 A CN 106794307A
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CN
China
Prior art keywords
housing
dose
dosage
dose setting
cartridge
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201580054519.0A
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Chinese (zh)
Other versions
CN106794307B (en
Inventor
Z·G·厄德利
P·R·德雷珀
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi SA
Sanofi Aventis France
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Sanofi Aventis France
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Publication of CN106794307A publication Critical patent/CN106794307A/en
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Publication of CN106794307B publication Critical patent/CN106794307B/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/202—Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2477—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means to reduce play of ampoule within ampoule holder, e.g. springs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154—Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code

Abstract

The present invention relates generally to a kind of delivery device for selecting and distributing the medicament of multiple user's variable doses.The device is connected to the drive member (40) of Dose setting member (60) and is connected to housing (10) and is connected to the piston rod (30) of drive member (40) including housing (10), the Dose setting member (60) that can be rotated relative to housing (10) during dosage setting and dosage are distributed, by clutch (120).Additionally, the device also includes：Cartridge-holder (20), it is removably attached to housing (10)；Reset element (150), it is constrained in Dose setting member (60) in the axial direction；At least one spring (130), it is acted in reset element (150), so that if cartridge-holder (20) is pulled down from housing (10), reset element (150) moves axially to dose setting member (60) and housing (10) is constrained in steering and allows drive member (40) relative to the position that housing (10) rotates relative to housing (10).

Description

Drug injection with the resetting-mechanism for allowing piston rod to retract when cartridge case is changed Device
Technical field
The present invention generally relates to select and distribute multiple user's variable doses medicament delivery device with And the method for assembling the delivery device.
Background technology
Pen-type drug delivery device can apply to be carried out by person without formal medical training the field of regular injections Close.This may be more and more universal in the patient with diabetes, and Heal Thyself enables that such patient efficiently controls Its disease.In practice, this delivery device allows user individually to select and distribute the medicine of multiple user's variable doses Thing.The present invention is not related to so-called fixed dosage device, and this fixed dosage device only allows to distribute predetermined close, without increasing The possibility of few setting dosage that adds deduct.
Substantially there is two kinds of delivery device：Can resetting means (that is, reusable) and the dress that can not reset Put (that is, disposable).For example, disposable pen type conveying device is provided as self-contained unit.This self-contained unit does not have can The pre-filled cartridge case for removing.Conversely, pre-filled cartridge case not breaking plant in itself in the case of can not be removed from these devices And replacing.Therefore, this disposable apparatus need not have reducible dosing mechanism.The present invention relates to reusable Device, its allow device reset and cartridge case replacing.The reset of device is usually directed to piston rod or driving screw from stretching out (distally) position (that is, the position after dosage distribution) moves to (nearside) position more retracted.
The pen type conveying device (so named because they are generally similar to the fountain pen for amplifying) of these types is logical Often include three main elements：Cartridge case section, it includes the cartridge case being commonly included in housing or retainer；Pin assembly, Its one end for being connected to cartridge case section；Metering section, its other end for being connected to cartridge case section.Cartridge case (commonly referred to ampoule) one As include：Reservoir, it is filled with medicament (for example, insulin)；Removable rubber-type stopper or obstruction piece, it is located at cartridge case storage One end of storage；Top, it has positioned at another pierceable rubber seal being usually at constriction end.Generally use crimping Be held in place for rubber seal by endless metal belt.Although cartridge case housing is typically made of plastics, cartridge reservoir history On be made up of glass.
Pin assembly is usually replaceable double-ended needle assembly.Before injection, by replaceable double-ended needle assembly One end of cartridge case assembly is attached to, then setting dosage feeds the dosage of setting.This removable pin assembly can be with spiral shell Line is connected to or pushes (that is, buckle) to the pierceable sealed end of cartridge case assembly.
Dosage section or dosing mechanism are usually for setting the part of (selection) dosage in pen device.In the injection phase Between, the heart axle or piston rod being contained in dosing mechanism are pressed against the stopper or obstruction piece of cartridge case.The power makes to be contained in cartridge case Interior medicament is injected by the pin assembly being attached.After injection, such as most drug conveying device and/or pin assembly system Business and supplier generally recommendation are made, pin assembly is removed and abandon.
Further discriminating between for delivery device type refers to drive mechanism.Some devices are manual actuations, for example, logical User is crossed to injection button applying power, some devices are driven by spring etc., and some devices are combined with the two concepts, i.e., still need User is wanted to apply the spring-assist devices of injection force.Spring type device include preload spring and during dosage choice by with The spring of family loading.Some energy storage devices additional-energy that user provides using spring preload and for example during dosage setting Combination.
The reusable medicine of manual actuation for example from the A1 of WO 2014/033195 and known to the B1 of EP 2 274 030 Thing conveying device.These devices include final dose mechanism, and the final dose mechanism prevents the dosage of setting from being remained in exceeding cartridge case Remaining pharmaceutical quantities.Changing cartridge case allows to promote piston rod to make the final dose mechanism with direction in opposite direction is distributed by edge Reset.
Additionally, the B1 of EP 1 819 382 disclose a kind of spring driven delivery device, it has housing, in agent The dosage that amount setting and dosage can rotate relative to housing during distributing between minimum dose position and maximum dosage position sets Determine component, the drive member of dose is connected to through ratchet mechanism and housing insert and can is threadedly coupled to The piston rod of drive member is constrained in steering.The device reset mentioned in the publication is different from above-mentioned definition, is conduct Reduce the process of set dosage.In the B1 of EP 1 819 382 cartridge case is changed without open and such as piston rod that resets.
The content of the invention
It is an object of the present invention to provide the improved reducible delivery device of one kind.
The purpose is solved by delivery device according to claim 1.Delivery device of the invention It is suitably selected for and distributes the medicine of multiple user's variable doses.The device generally includes housing, dose, via clutch Device is connected to the drive member of dose and is connected to housing and is connected to the piston rod of drive member.Preferably Be, dose can during dosage setting (that is, increasing or decreasing dosage) and dosage are distributed relative to housing most Rotated between low dose of position and maximum dosage position.Drive member be able to can revolve during dosage setting via slip-clutch It is connected to dose with turning, and dose is constrained in steering during dosage is distributed.The present invention is based on Design be to provide the cartridge-holder and reset element for being detachably attached to housing.Reset element is preferably in axial direction On be constrained in Dose setting member.Additionally, the device can include at least one spring, at least one spring effect is resetting On element so that if cartridge-holder is pulled down from housing, reset element is moved axially to relative to housing allows to drive Dynamic component is relative to the position that housing rotates.Preferably, reset element is made to move axially to dosage setting unit relative to housing Part is constrained in the position of housing in steering.In other words, pull down cartridge-holder from housing, it is allowed to reset element and preferably Be acceptable dose setting element move axially to reset position, in reset position, drive member can be relative to housing simultaneously And rotated relative to dose.When piston rod is connected into housing and drive member, for example via with housing or shell Hickey and the spline interface with drive member formation that body plug-in unit is formed, the reset of piston rod need drive member freedom Rotation.Therefore, it can perform drug delivery simply by pushing back piston rod or driving screw after cartridge-holder is removed The reset of device.
If cartridge-holder is attached to housing, cartridge-holder is preferably and overcomes at least one spring Reset element and Dose setting member are moved to the position that Dose setting member can rotate relative to housing by deflection.Therefore, it is attached Connect device is locked in cartridge-holder acceptable dose setting and dosage distribution dosage setting and dosage allocation model, the pattern Dose setting member is needed to be rotated relative to housing.
In a preferred embodiment of the invention, reset element is for good and all constrained in housing in steering.This allows multiple Bit unit by by reset element and building block out of engagement with and being locked in steering or unlock building block (constraint or not Constraint building block).Axial movement of the reset element between reset mode and dosage setting and dosage allocation model, can be used for Building block is connected to housing or is disconnected with housing.
According to one embodiment, drive member can be relative to housing between dose setting position and dosing position Axial movement, in dose setting position, drive member is constrained in housing via reset element in steering, in dosing position In, drive member can rotate relative to reset element and housing.In other words, the axial location of drive member determines device It is to be in dosage allocation model in dosage setting pattern, under dosage setting pattern, it is allowed to which user is regardless of dose out powders In the case of dosage is increased or decreased by the rotation of dose, under dosage allocation model, it is allowed to which user passes through The rotation of Dose setting member and drive member distributes the dosage of setting.Preferably, at least one spring causes drive Dynamic component is partial to enter its dose setting position.
In the further development of the embodiment, the clutch between Dose setting member and drive member be slide from Clutch, slip-clutch has the first clutch tooth in drive member and the second clutch tooth in clutch disc, should Clutch disc is constrained in Dose setting member during dosage setting and dosage are distributed in steering.For example, first and/or second Clutch teeth can be distributed a circle tooth, preferably face a circle tooth of axial direction.Clutch configuration and corresponding clutch Device structure can all include a series of teeth, preferably sawtooth, these teeth if being pressed against each other less firmly, then Allow mutually to slip over.In other words, clutch configuration can overcome clutch spring by allowing sleeve and/or clutch element Power axial translation, and overcome the axial deflection of clutch spring and be exceeded.It is re-engaged due to constantly departing from and afterwards To next stop position, overrun clutch structure may cause the vibration of sleeve and/or clutch element to be axially moved.Can be with The audible click of generation is re-engaged by this, and the change that can be input into by required moment of torsion is anti-to provide tactile Feedback.
At least one spring may cause to drive member be partial to clutch disc against.If cartridge-holder quilt Pulled down from housing, then at least one spring may cause to Dose setting member and be partial to enter clutch relative to clutch disc The axial location that device piece and Dose setting member disconnect in steering.This allows drive member to be revolved relative to Dose setting member Turn, and slip-clutch need not be overcome.
Preferably, the clutch between drive member and dose is slip-clutch, and it allows to drive structure Rotated against in the two directions during dosage setting between part and dose, the agent for increaseing or decreasing setting Amount.If device is actuating device of the spring, clutch teeth may be designed to according to the direction that rotates against provide for overcome from The different resistances of clutch.For example, ramp angle can be gentle, the resistance for causing dosage to increase on direction is small, and ramp angle can be steep, leads The resistance for causing dosage to reduce on direction is high.
Housing can include inwardly projecting wall or web, and the inwardly projecting wall or web have central opening and at least Another opening, wherein in cartridge-holder and reset element include extending through at least the one of another opening Individual axially extending finger or similar projection.This is allowed from cartridge-holder to reset element applying power or movement, otherwise Also may be used.Preferably, inwardly projecting wall or web include internal thread, and wherein piston rod is constrained in drive member simultaneously in steering And including engaging the external screw thread of internal thread.
Delivery device can also include at least one cartridge-holder spring, at least one cartridge-holder bullet Spring is in the axial direction between cartridge-holder and inwardly projecting wall or web.The other spring can compensate the length of cartridge case Spend tolerance and cartridge case is in the distal position for limiting.
According to a preferred embodiment, delivery device is actuating device of the spring.Driving spring, preferably reverses bullet Spring, can be between housing and Dose setting member.The flexible drive structure of the power or moment of torsion needed for producing dosage distribution is provided Part, such as torsionspring, reduce the power for dosage distribution of user's applying.This is for the user with impaired flexibility Speech is particularly useful.Further, since known manual driving device selects extensions caused by distribution stroke, can be by offer Elastic component is omitted, because only needing the triggering stroke of very little to discharge elastic component.Driving spring can be pre- at least in part Load and/or can be loaded by user during dosage setting.
In a further advantageous embodiment, delivery device is additionally included in radially between housing and dose Between measuring element.Measuring element can be moved axially relative to housing and is threadedly engaged with Dose setting member.Housing At least one hole can be included, and measuring element can include at least one hole.If dose is in its appearance Include the digital sleeve of mark on face, then during dosage setting and dosage are distributed, at least one mark can be by measuring unit The hole of part and the hole of housing are seen.Term " hole " can be included in simple opening in housing or measuring element or transparent window or Lens." double injection (twin-shot) " forming technique can be used to combine in the housing window.For example, housing is " for the first time Moulded with trnaslucent materials during injection ", and the overcoating part opaque material of housing molding during " second injection ".
Measuring element can be axially guided in housing so that the rotation of Dose setting member causes measuring element Axial displacement.Therefore, the position of measuring element can be used for recognizing the dosage of actual set and/or distribution.In metering element not Can be in order to recognize the dosage for setting and/or distributing, without reading numeral, symbol on display with the section of color Deng.When measuring element and Dose setting member are threadedly engaged, the rotation of Dose setting member causes measuring element relative to agent Amount setting element and the axial displacement relative to housing.Measuring element can have the cover for extending in the longitudinal direction of the device Or the form of band.Alternatively, measuring element can be sleeve.In one embodiment of the invention, Dose setting member mark Note has numeral or the symbol sebolic addressing being arranged on spiral path.The feelings of the radially inner side of measuring element are located in dose Under condition, at least one of numeral or symbol on this acceptable dose setting element are visible by hole or window.In other words Say, measuring element can be used for covering or covering a part for Dose setting member, only allow to see having for dose Limit part.The function can be that measuring element is suitable in itself to recognize or actual set is indicated and/or the benefit of the dosage of distribution Fill.
Generally speaking, the concept of measuring element and Dose setting member is applied to or without the various of driving spring The device of type.In a preferred embodiment, dose is suitable in housing and relative during dosage setting Pure rotary motion is experienced in housing.In other words, Dose setting member does not perform translational motion during dosage setting.This Dose setting member is avoided to be screwed out from housing, or housing must be lengthened out and be covered in housing with by Dose setting member It is interior.
The relative motion of measuring element and Dose setting member can also be used to limit minimum dose position and maximum dose position Put.In general, most I setting dosage is zero (0IU insulin formula) so that limiter stops at the end of dosage is distributed Device.Can limit such as 60,80 or 120 maximums of the insulin preparation of IU can setting dosage, to reduce overtreatment Risk, and the extra spring torque needed for avoiding distributing very high dose, while standing good in needing various dose The extensive patient of size.Preferably, the limitation to minimum dose and maximum dose is provided by hard stop configurations.For example, meter Amount element includes that minimum dose rotates backstop and maximum dose rotation backstop, and Dose setting member rotates including minimum dose Pairing backstop and maximum dose rotation pairing backstop.Corresponding backstop and pairing stop part against preventing measuring element and agent Further relative motion between amount setting element.Due to dosage indicator during dosage setting and during dosage is distributed Relative to measuring element rotation, both parts are suitable for forming reliable and firm limiters mechanisms.
The device can also include distribution button or trigger.Button is preferably located at drive sleeve and clutch element The operable element of user of nearside.When being used in delivery device, button can stretch out from the near-end of device, and excellent Choosing, its axial location is not changed during dosage setting.Button is preferably and is connected to the exercisable dosage choice of user Device and it is releasably attached to digital sleeve part and/or motionless housing parts.In an alternative embodiment, button can Being a part for dose setting device, or it can be dose.Button can be except said structure also has Such as multifunctional element of thump acoustical generator structure etc..
Motionless housing parts are the relative motions for axially movable (driving) sleeve, clutch element and button Immobilizing foundation.It can be Multi-part housing a part or can be delivery device unique housing parts.The shell Body component can also have such as thump acoustical generator structure and/or the interface etc. formed with piston rod in addition to the foregoing structure Multifunctional element.
Delivery device can also be included for preventing setting more than the last agent of the dosage of residual liquid quantity in cartridge case Amount protection mechanism.Advantage including the mechanism is, before starting dose conveying user know will conveying it is more a small amount of.It also ensure that Dosage conveying stops in a controlled manner, stopper is not entered the less neck of diameter of cartridge case, and stopper enters the small of cartridge case Diameter neck portion may cause underdosage.For example, final dose protection mechanism is included between drive member and Dose setting member (digital sleeve) or the nut member between any other part rotated during dosage setting and dosage are distributed.It is excellent at one Select in embodiment, Dose setting member rotates during dosage setting and during dosage is distributed, and drive member is only in dosage point Rotated together with dose with period.Therefore, in this embodiment, nut member will be only during dosage setting axially It is mobile, and will be remained stationary as relative to these parts during dosage is distributed.Preferably, nut member is threadedly coupled to driving Component, and spline connection is to dose.Alternatively, nut member can be threadably connected to dose, and Drive member can be splined.Nut member can be full nut, or one part, such as halfnut.
Injection device can include at least one thump the acoustical generator mechanism for producing tactile and/or audio feedback. Can be produced during dosage setting (increasing and/or reduce dosage), at the end of being distributed during dosage is distributed and/or in dosage anti- Feedback.
Delivery device can include the cartridge case containing medicament.Term " medicament " (medicament) meaning used herein Refer to the pharmaceutical formulation containing at least one pharmaceutically active compound,
Wherein in one embodiment, the pharmaceutically active compound have up to the molecular weight of 1500Da and/or Person is peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or its fragment, hormone or oligonucleotides, or above-mentioned pharmacy is lived The mixture of property compound,
Wherein in still another embodiment, the pharmaceutically active compound for treat and/or prevention diabetes or with The relevant complication of diabetes, such as diabetic retinopathy (diabetic retinopathy), thromboembolic disorders (thromboembolism disorders) such as Deep venou or pulmonary thromboembolism, acute coronary syndrome (acute Coronary syndrome, ACS), it is angina pectoris, myocardial infarction, cancer, macular degeneration (macular degeneration), scorching Disease, hay fever, atherosclerosis and/or rheumatoid arthritis be it is useful,
Wherein in still another embodiment, the pharmaceutically active compound includes at least one for treatment and/or pre- The peptide of anti-diabetes or the complication relevant with diabetes (such as diabetic retinopathy),
Wherein in still another embodiment, the pharmaceutically active compound includes at least one actrapid monotard or people's pancreas islet Plain analog or derivative, glucagon-like peptide (glucagon-like peptide, GLP-1) or its analog or derivative Thing or Exendin -3 (exedin-3) or exendin-4 (exedin-4) or Exendin -3 or exendin The analog or derivative of peptide -4.
Insulin analog such as Gly (A21), Arg (B31), Arg (B32) actrapid monotard；Lys (B3), Glu (B29) people Insulin；Lys (B28), Pro (B29) actrapid monotard；Asp (B28) actrapid monotard；The proline of actrapid monotard, wherein B28 It is replaced by Asp, Lys, Leu, Val or Ala and the lysine of wherein B29 could alternatively be Pro；Ala (B26) people's pancreas islet Element；Des (B28-B30) actrapid monotard；Des (B27) actrapid monotard；With Des (B30) actrapid monotard.
Insulin derivates such as B29-N- myristoyls-des (B30) actrapid monotard；B29-N- palmityls-des (B30) Actrapid monotard；B29-N- myristoyl human insulins；B29-N- palmitoyl human insulins；B28-N- myristoyls Lispro；B28-N- palmityls-Lispro；B30-N- myristoyls- ThrB29LysB30 actrapid monotards；B30-N- palmityl-ThrB29LysB30 actrapid monotards；B29-N- (N- palmityls-Υ-paddy Aminoacyl)-des (B30) actrapid monotard；B29-N- (N- stone courage acyls-Υ-glutamy)-des (B30) actrapid monotard；B29-N-(ω- Carboxyl heptadecanoyl)-des (B30) actrapid monotards and B29-N- (ω-carboxyl heptadecanoyl) actrapid monotard.
Exendin-4 means such as exendin-4 (1-39), and it is the peptide with following sequences：H His- Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg- Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pr o-Pro-Ser- NH2。
Exendin-4 derivative is selected from following compound lists：
H- (Lys) 4-des Pro36, des Pro37 exendin-4 (1-39)-NH2,
H- (Lys) 5-des Pro36, des Pro37 exendin-4 (1-39)-NH2,
Des Pro36 exendin-4s (1-39)
Des Pro36 [Asp28] exendin-4 (1-39),
Des Pro36 [IsoAsp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14, Asp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14, IsoAsp28] exendin-4 (1-39),
Des Pro36 [Trp (O2) 25, Asp28] exendin-4 (1-39),
Des Pro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14Trp (O2) 25, IsoAsp28] exendin-4 (1-39)；Or
Des Pro36 [Asp28] exendin-4 (1-39),
Des Pro36 [IsoAsp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14, Asp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14, IsoAsp28] exendin-4 (1-39),
Des Pro36 [Trp (O2) 25, Asp28] exendin-4 (1-39),
Des Pro36 [Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39),
Des Pro36 [Met (O) 14Trp (O2) 25, IsoAsp28] exendin-4 (1-39),
Wherein-Lys6-NH2 groups can be incorporated into the C-terminal of exendin-4 derivative；
Or the exendin-4 derivative of following sequences
Des Pro36 exendin-4 (1-39)-Lys6-NH2 (AVE0010)
H- (Lys) 6-des Pro36 [Asp28] exendin-4 (1-39)-Lys6-NH2,
Des Asp28Pro36, Pro37, Pro38 exendin-4 (1-39)-NH2,
H- (Lys) 6-des Pro36, Pro38 [Asp28] exendin-4 (1-39)-NH2,
H-Asn- (Glu) 5des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-NH2,
Des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39)-(Lys) 6- NH2,
H- (Lys) 6-des Pro36 [Trp (O2) 25, Asp28] exendin-4 (1-39)-Lys6-NH2,
H-des Asp28Pro36, Pro37, Pro38 [Trp (O2) 25] exendin-4 (1-39)-NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)- NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1- 39)-NH2,
Des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39)- (Lys)6-NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1- 39)-(Lys)6-NH2,
H- (Lys) 6-des Pro36 [Met (O) 14, Asp28] exendin-4 (1-39)-Lys6-NH2,
Des Met (O) 14Asp28Pro36, Pro37, Pro38 exendin-4 (1-39)-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)- NH2,
Des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)- (Lys)6-NH2,
H-Asn- (Glu) 5des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)- (Lys)6-NH2,
H-Lys6-des Pro36 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)-Lys6- NH2,
H-des Asp28Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] exendin-4 (1-39)- NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin Peptide -4 (1-39)-NH2,
Des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (1-39)- (Lys)6-NH2,
H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin-4 (S1-39)-(Lys)6-NH2,
H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] exendin Peptide -4 (1-39)-(Lys) 6-NH2；
Or the pharmaceutically acceptable salt or solvate of foregoing any one exendin-4 derivative.
Pituitrin (the hypophysis that hormone is for example listed in Rote Liste, ed.2008, the 50th chapter ) or hypothalamic hormone (hypothalamus hormones) or modulability active peptide (regulatory active hormones Peptides) and their antagonist, such as promoting sexual gland hormone (follitropic hormone (Follitropin), metakentrin (Lutropin), human chorionic gonadtropin (Choriongonadotropin), Menotrophins (Menotropin)), Somatropine (growth hormone (Somatropin)), minirin (Desmopressin), terlipressin (Terlipressin), Gonadorelin (Gonadorelin), Triptorelin (Triptorelin), Leuprorelin (Leuprorelin), Buserelin (Buserelin), nafarelin (Nafarelin), Goserelin (Goserelin).
Polysaccharide such as glucosaminoglycan (glucosaminoglycane), hyaluronic acid (hyaluronic acid), liver Element, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or foregoing polysaccharide sulphation, such as poly-sulfated shape Formula, and/or its pharmaceutically acceptable salt.One example of the pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is according to promise liver Plain sodium (enoxaparin sodium).
Antibody is spherical plasma proteins (~150kDa), also referred to as immunoglobulin, and it has a kind of foundation structure.Cause For they have the sugar chain added to amino acid residue, so they are glycoprotein.The basic function unit of each antibody is to exempt from Epidemic disease globulin (Ig) monomer (only contains an Ig unit)；The antibody of secretion can also have two dimers of Ig units such as IgA, the IgM with four tetramers of Ig units such as bony fish (teleost fish) or poly- with five the five of Ig units The IgM of body such as mammal.
Ig monomers are Y-shaped molecules, and it is made up of four polypeptide chains；Two identical heavy chains and two identical light chains, They are by the disulfide bond between cysteine residues.Every heavy chain is about 440 amino acid；Every light chain is about 220 Individual amino acid.Every heavy chain and light chain contain intrachain disulfide bond, and intrachain disulfide bond stablizes their folding.Every chain is all by claiming For the domain in Ig domains is constituted.About 70-110 amino acid is contained in these domains, and is returned according to their size and function classification Enter different categories (for example, variable or V, constant or C).They have the immunoglobulin folding of characteristic, two of which β pieces Layer creates a kind of " sandwich " shape, and the shape is by the phase interaction between the cysteine guarded and other electrically charged amino acid With and keep together.
Mammal Ig heavy chains have five types, are expressed as α, δ, ε, γ and μ.The type of the heavy chain of presence determines antibody Isotype；These chains can find in IgA, IgD, IgE, IgG and IgM antibody respectively.
The size and composition of different heavy chains are different；α and γ contain about 450 amino acid, and δ contains about 500 Individual amino acid, and μ and ε has about 550 amino acid.Every heavy chain has Liang Ge areas, i.e. constant region (CH) and variable region (VH).In a species, constant region is substantially the same in all antibody of same isotype, but of the same race in difference It is different in the antibody of type.Heavy chain γ, α and δ have comprising three constant regions in series connection Ig domains, and for increasing the strand of flexibility Sequence；Heavy chain μ and ε have comprising four constant regions of immunoglobulin domain.The variable region of heavy chain is being generated by different B cells It is different in antibody, but it is identical for by single B cell or all antibody of single B cell clone's generation. The variable region of every heavy chain is of about 110 amino acid longs and comprising single Ig domains.
In mammal, there is two kinds of light chain immunoglobulin, be expressed as λ and κ.Light chain has two continuously Domain：One constant domain (CL) and a variable domain (VL).Light chain about 211 to 217 amino acid long.Each antibody contains two Light chain, their always identicals；Each antibody only exists a type of light chain, κ or λ in mammal.
As detailed above, although the general structure of all antibody is closely similar, but the peculiar property of given antibody is Determined by variable (V) area.More specifically, variable loop -- it respectively has three on light chain (VL) and on heavy chain (VH) -- is responsible for With reference to antigen, i.e. antigentic specificity.These rings are referred to as complementary determining region (Complementarity Determining Regions, CDRs).It is heavy chain and light chain because the CDR from VH and VL domains is contributed to antigen binding site Combination, rather than wherein independent one, determines final antigentic specificity.
" antibody fragment " contains at least one antigen-binding fragment as defined above, and is presented complete with derivative antibody fragment Whole antibody substantially the same function and specificity.It is with papain (papain) restricted proteolytic digestion that Ig is former Type is cracked into three fragments.Two identical amino end segments are antigen-binding fragment (Fab), each fragment contain one it is complete Whole L chains and only about half of H chains.3rd fragment is FC (Fc), its size it is similar but comprising be two heavy chains The half of carboxyl terminal, and possess interchain disulfide bond.Fc contains sugar, complement-binding site and FcR binding sites.It is restricted Pepsin (pepsin) digestion produce the fragments of single F (ab') 2 containing two Fab and hinge area, it includes H-H interchains Disulfide bond.F (ab') 2 is divalence for antigen binding.The disulfide bond of F (ab') 2 can crack to obtain Fab'.This Outward, can be by the variable region fusion of heavy chain and light chain to together forming single chain variable fragment (scFv).
Pharmaceutically acceptable salt such as acid-addition salts and basic salt.Acid-addition salts such as HCl or HBr salt.Basic salt for example has Have the cation selected from alkali or alkaline earth, such as Na+ or K+ or a Ca2+, or ammonium ion N+ (R1) (R2) (R3) (R4) salt, its Middle R1 to R4 is independently of one another：Hydrogen, optionally substituted C1-C6 alkyl, optionally substituted C2-C6 alkenyls, optionally substituted C6- C10 aryl or optionally substituted C6-C10 heteroaryls.More examples of pharmaceutically acceptable salt are in " Remington's Pharmaceutical Sciences"17.ed.Alfonso R.Gennaro(Ed.),Mark Publishing Company, In Easton, Pa., U.S.A., 1985 and described in Encyclopedia of Pharmaceutical Technology.
Pharmaceutical acceptable solvents compound such as hydrate.
Brief description of the drawings
The non-limiting exemplary embodiment that the invention will now be described with reference to the accompanying drawings, in the accompanying drawings：
Fig. 1 show the top view of delivery device of the present invention；
Fig. 2 show the exploded view of all parts of Fig. 1 devices；
Fig. 3 show the sectional view of Fig. 1 devices；
Fig. 4 show the side view of the measuring element of Fig. 1 devices；
Fig. 5 show the details of the digital sleeve of Fig. 1 devices；
Fig. 6 show the sectional view of Fig. 1 device details；
Fig. 7 a, Fig. 7 b show Fig. 1 devices in dosage setting pattern and the sectional view of dosage allocation model；
Fig. 8 a, Fig. 8 b show the details of Fig. 7 a, Fig. 7 b；
Fig. 9 show the details of Fig. 1 devices；
Figure 10 show the side view of the cartridge-holder spring of Fig. 1 devices；
Figure 11 show the details of Fig. 1 devices；
Figure 12 a to Figure 12 c show the sectional view of Fig. 1 device reseting sequences；
Figure 13 show one details of alternate embodiment of delivery device of the present invention.
Specific embodiment
Fig. 1 shows delivery device in the form of injection pen.The device has distal end (left end in Fig. 1) and near-end (right-hand member in Fig. 1).Figure 2 illustrates the building block of delivery device.Delivery device include main body or housing 10, Cartridge-holder 20, driving screw (piston rod) 30, drive sleeve 40, nut 50, as dosage indicator (digital sleeve) 60 Dose setting member, button 70, select handle or dosage selector 80, torsionspring 90, cartridge case 100, measuring element 110, from Clutch piece 120, clutch spring 130, supporting member 140, restoring board 150 and cartridge-holder spring 160.With needle stand and needle cover Pin assembly can be provided as additional component, pin assembly can be changed as explained above.All parts All positioned with one heart around the mechanism common shaft line I shown in Fig. 3.
Housing 10 or main body are the generic tubular elements of the diameter that near-end has increase.Housing 10 is liquid preparation cartridge case 100 and cartridge-holder 20 provide position, be observation dosage indicator 60 on dosage numbers and measuring element 110 provide window 11a, 11b, and provide on its outer surface to the structure of maintenance dosage selector 80 in the axial direction, such as circumferential recess. In another embodiment, it is possible to have a big window.Then, the opaque bridge part between window 11a and 11b is saturating Area pellucida domain replaces.Flange shape or cylindrical inwall 12 includes the internal thread of engaging piston bar 30.Housing 10 also has is used for axle Notch of at least one inside axial orientation to guiding measuring element 110 etc..In the embodiments illustrated in the figures, distal end is set There is axially extending band 13 partly overlapping with cartridge-holder 20.Housing 10 is depicted as single shell part in figure.However, shell Body 10 can include two or more housing parts, it is described two can be for good and all attached during the assembling of device with top shell component It is connected to together.
Cartridge-holder 20 is located at the far-end of housing 10 and is releasably attached to housing 10.Cartridge case keeps Device can be transparent or semitransparent part, its be tubulose be used to receive cartridge case 100.The distal end of cartridge-holder 20 can set It is equipped with the device for being attached pin assembly.Removable lid (not shown) can be provided, for being enclosed within cartridge-holder 20, And can be via clamp structure maintenance on the housing 10.Cartridge-holder 20 includes replaceable cartridge case 100, and for inciting somebody to action The spline tooth 151 of restoring board 150 is axially aligned with the spline tooth 41 of drive sleeve 40.When cartridge-holder 20 is removed, touch Hair device spring 130 forces restoring board 150 (and Dose setting member 60) to be axially displaced toward distal direction, makes restoring board 150 and drives Spline tooth 41 and 151 between moving sleeve 40 and the spline tooth between clutch disc 120 and Dose setting member 60 depart from, and permit Perhaps the device is reset.
Piston rod 30 is constrained in drive sleeve 40 through spline interface in steering.When, upon rotating, piston rod 30 by its with Being threadedly engaged for the formation of housing 10 is forced axial movement relative to housing 10.
Drive sleeve 40 extends always from the interface 42,121 (via clutch disc 120) formed with Dose setting member 60 To the spline tooth interface 41,151 (Fig. 6) formed with restoring board 150.This provides steering during dosage setting to drive sleeve 40 Constraint.When button 70 is pressed, these spline tooths 41,151 depart from, it is allowed to which drive sleeve 40 is in the presence of driving spring 90 Rotation, distributes the dosage of setting.Pressing button 70 also causes spline other between drive sleeve 40 and Dose setting member 60 Clutch 43,61 engages (Fig. 7 a).
Final dose nut 50 is located between Dose setting member 60 and drive sleeve 40.Final dose nut 50 is by flower Bonded mouth is constrained in Dose setting member 60 in steering.It is relative when occurring between Dose setting member 60 and drive sleeve 40 When rotation is (only during selecting and resetting), final dose nut 50 is by hickey 44 relative to drive sleeve 40 along spiral Move in path.
Dose setting member 60 is restrained to restoring board 150 by the clip of its far-end, select and distribution state under Rotation is allowed, but does not allow axial translation.When reset state is entered, restoring board 150 and Dose setting member 60 are distad square To axial movement, the spline interface 62,14 between Dose setting member 60 and housing 10 is engaged, rotated during preventing from resetting (Figure 12 a to 12c).As shown in figure 5, Dose setting member 60 is marked with Serial No., the sequence can be by measuring element 110 In opening 111 (Fig. 4) and housing 10 in notch-like window 11b see, represent selected drug dose.
When under dose dial state, the spline connection of button 70 is in Dose setting member 60.It is pressed to touch when button 70 During hair distribution, the spline interface disconnects.
Dosage selector 80 is diametrically constrained in housing 10, and button 70 is constrained in steering.When button 70 is pressed It is bonded in steering by spline and is constrained in housing 10.
One end of driving spring 90 is attached to housing 10, and the other end is attached to Dose setting member 60.Driving spring 90 exists Wound in advance during assembling so that when mechanism is in has selected zero quantity, driving spring 90 applies moment of torsion to dosage setting unit Part 60.Dose selector 80 makes Dose setting member 60 be rotated relative to housing 10 with the action of setting dosage, and right Driving spring 90 is loaded.
Measuring element 110 is restrained in case spin-ended turn, but permission is translated via spline interface relative to housing 10.Metering Element 110 on its inner surface have helical structure 112, helical structure 112 be formed in Dose setting member 60 Screw 63 is engaged so that the rotation of Dose setting member 60 causes the axial translation of measuring element 110.Measuring element 110 On these helical structures also produce backstop butting section against helical cuts (screw thread) end in Dose setting member 60, use To limit settable minimum and maximum dosage.
Clutch disc 120 in select and distribute state when spline connection to Dose setting member 60.Resetted entering During state, the axial movement of the distal direction of Dose setting member 60 makes the spline interface be disconnected with clutch disc 120.Clutch Piece 120 is also connected to drive sleeve 40 (Fig. 7 a) via ratchet mechanism interface 42,121, the connection occur axially against when.Spine Wheel mechanism provides stop position corresponding with each incremental dose between Dose setting member 60 and drive sleeve 40, and The different inclination tooth angle of engagement during rotating against clockwise and anticlockwise.
The effect of the toggled device spring 130 in position to axial of drive sleeve 40, clutch disc 120 and button 70 Influence, the proximal direction of trigger spring 130 applies deflection force to drive sleeve 40.In spare space, this ensures button 70 Spline 71 is engaged with the spline 64 of Dose setting member 60, and ensures the tooth 41 of drive sleeve 40 and the tooth 151 of restoring board 150 Engagement (Fig. 8 a, Fig. 8 b).
Supporting member 140 is constrained in piston rod 30 and acts on the stopper in liquid preparation cartridge case 100 in the axial direction.
Restoring board 150 is connected to housing 10 turning to upper spline, and by the distal direction of trigger spring 130 be biased against in Cartridge-holder 20.Restoring board 150 is included：Spline tooth 151, it prevents drive sleeve 40 from rotating in the period that selects of device；Folder Son, its be used to prevent Dose setting member 60 select and distribution state under be axially moved.Restoring board 150 is clamped to housing Limiting the range of movement of its proximal direction in 10.
Cartridge-holder spring 160 is acted between housing 10 and cartridge case 100, causes the distal direction of cartridge case 100 inclined.
The major function of the device will be described in further detail now.It is under stand-by state as shown in Figure 3 in device, agent The zero-dose butting section positioning that amount setting element 60 is formed against it with measuring element 110, and do not press button 70.Dosage sets Determining the dosage indicia " 0 " on element 60 can be seen by the window 11b of housing 10 and measuring element 110.During device is assembled The driving spring 90 of winding multi-turn applies torsion moment to Dose setting member 60 in advance, and prevents rotation by zero-dose butting section. Mechanism can also be made somewhat " due to the angle deviating of the deviation between zero-dose backstop and drive sleeve spline tooth 41 Turn ".This have the effect that, when dosage selected and zero-dose butting section depart from when prevent possible seepage.
User selects the liquid preparation of variable dose by turning clockwise dosage selector 80, and this is in dosage setting unit Identical rotation is produced in part 60.The rotation of Dose setting member 60 causes the loading of driving spring 90, increased and is stored in it In energy.When Dose setting member 60 rotates, the axial translation due to its threaded connection 63,112 of measuring element 110, So as to show the value of selected dosage.Measuring element 110 has opaque surface (flange) in the both sides of window area 111, The opaque surface covering is printed on the numeral adjacent with the dosage for being selected on Dose setting member 60, to ensure only There are the dosage numbers of setting visible to user.
In addition to the discrete doses digital display generally on such device, a specific unit of the mechanism Element also includes visual feedback feature.The distal end of measuring element 110 produces the slide rule by the wicket 11a of housing 10 (if needed If wanting, slide rule can use the single part engaged with Dose setting member 60 on different helical orbits to be formed).When During user's setting dosage, the axial translation of measuring element 110, the distance for being moved is proportional to the size of the dosage of setting.The spy Levy and provide a user with the clear feedback on set dosage approximate size.The dispensing rate of automatic injector mechanism could possibly be higher than The dispensing rate of hand gun device, it is thus possible to cannot during distribution read numerical dosage and show.Measuring element 110 This feature provides a user with the feedback on distributing progress during distribution, without reading dosage numbers in itself.
The display of measuring element 110 can appear following contrast colour cell and be formed by opaque sliding members.As Substitute, hiding part can be printed on runic (interim) dosage numbers or other marks to provide more accurate resolution ratio.In addition, meter Syringe action during the amount display of element 110 simulation dosage setting and distribution.
In setting dosage, drive sleeve 40 is prevented from rotating because its spline tooth 41 is engaged with restoring board 150, and from Clutch piece 120 rotates (Fig. 8 a, 8b) because its spline tooth 122 is engaged with the tooth 65 of Dose setting member 60.Therefore, relative rotation Turn necessarily by the generation of ratchet mechanism interface 121,42 between clutch disc 120 and driver sleeve 40.
User's moment of torsion needed for rotating dosage selector 80 is moment of torsion needed for rolling tightly driving spring 90 and surmounts spine The summation of the moment of torsion needed for wheel construction.Trigger spring 130 is designed to provide axial force to ratchet structure, and causes clutch disc 120 are partial to be located in drive sleeve 40.The axial load is used to maintain the ratchet toe joint of clutch disc 120 and drive sleeve 40 Close.Moment of torsion needed for surmounting ratchet mechanism on dosage setting direction is axial load, the ratchet machine that trigger spring 130 applies The function of the mean radius of coefficient of friction and ratchet structure between ramp angle clockwise, the matching surface of structure.
When user makes the rotation of dosage selector 80 be enough to make mechanism increase by 1 increment, clutch disc 120 is relative to driving Sleeve 40 rotates through 1 hook tooth 121,42.Now, hook tooth is re-engaged next application position.Audible click Sound is re-engaged generation by ratchet mechanism, and the palpable change for feding back through required moment of torsion input is provided.
Dose setting member 60 and rotating against for drive sleeve 40 cause final dose nut 50 along its thread path court Its final dose butting section in drive sleeve 40 to advance.
In the case where user's moment of torsion is not applied to dosage selector 80, now only by clutch disc 120 and driving Ratchet mechanism junction surface 121 and 42 between sleeve 40, prevents Dose setting member 60 from being turned round in the presence of driving spring 90. Moment of torsion needed for surmounting ratchet mechanism 121,42 in the counterclockwise direction is axial load, the ratchet machine that trigger spring 130 applies The function of the mean radius of coefficient of friction and ratchet structure between ramp angle counterclockwise, the matching surface of structure.Surmount ratchet institute The moment of torsion for needing have to be larger than the torsion that driving spring 90 is applied to Dose setting member 60 (and being therefore applied to clutch disc 120) Square.Therefore, ratchet mechanism ramp angles increase in the counterclockwise direction, to ensure such case, while ensure to select moment of torsion can Receive low.
User can select to increase selected dose by continuing to be rotated in a clockwise direction dosage selector 80 now Amount.For each incremental dose, repetition surmount ratchet mechanism interface 121 between Dose setting member 60 and drive sleeve 40, 42 process.For each incremental dose, extra energy stores are in driving spring 90, and connecing again by hook tooth It is combined into each increment for being selected and the sense of hearing and touch feedback is provided.Moment of torsion needed for dose selector 80 is with rolling tightly driving The increase of the moment of torsion needed for spring 90 and increase.Therefore, the moment of torsion needed for ratchet being surmounted in the counterclockwise direction have to be larger than and reach The moment of torsion of Dose setting member 60 is applied to during maximum dose by driving spring 90.
If user continues to increase selected dosage until reaching maximum dose limit, Dose setting member 60 and its Maximum dose butting section (Fig. 4 and Fig. 5) on measuring element 110 engages.This prevents Dose setting member 60, clutch disc 120 and dosage selector 80 further rotate.
How many increment (counting), during selective dose, final dose nut delivered depending on mechanism's (cartridge case) 50 can contact the final dose butting section that it is formed with drive sleeve 40.The butting section prevents Dose setting member 60 and drives Further rotated against between sleeve 40, therefore limit the dosage that can be selected.The position of final dose nut 50 is by each When user sets dosage between Dose setting member 60 and drive sleeve 40 accumulation get up rotate against total decision.
In the mechanism in the state of dosage is had selected for, user can cancel any number of selection from the dosage The increment (dose modification) of amount.User is cancelled by dose selector 80 in the counterclockwise direction or reduces dosage.User The moment of torsion of dosage selector 80 is applied to, is combined with the moment of torsion applied by driving spring 90, it is sufficient to surmount in the counterclockwise direction Ratchet mechanism 121,42 between clutch disc 120 and drive sleeve 40.When ratchet mechanism is exceeded, in Dose setting member There is rotate counterclockwise (via clutch disc 120) in 60, Dose setting member 60 is returned towards zero dose position, and make drive The loose exhibition of spring 90 of moving.Rotating against between Dose setting member 60 and drive sleeve 40 causes final dose nut 50 along it Spiral path is returned, away from final dose butting section.
The mechanism be in dosage it is selected in the state of, user can actuating mechanism starting delivered dose. The conveying of dosage axially presses button 70 to start by user.
When button 70 is pressed, the spline 64,71 between button 70 and Dose setting member 60 departs from, and makes button 70 and agent Amount selector 80 disconnects with conveying mechanism in steering.Spline 71 on button 70 is also engaged with the spline 15 on housing 10 and (made Obtain dosage selector 80 and button 70 does not rotate during distribution, referring to Fig. 8 a and Fig. 8 b).The power of button 70 is through clutch disc 120 are acted in drive sleeve 40, and drive sleeve 40 is axially advanced, and disconnection is engaged with the spline of restoring board 150, it is allowed to actuating sleeve Cylinder 40 rotates.Clutch disc 120 to the power of the ratchet mechanism of drive sleeve 40 is acted on, by the compression of trigger spring 130 And increase so that these parts rotate together via Dose setting member 60 under the driving of driving spring 90, rather than surmounting Ratchet mechanism 121,42.The rotation of drive sleeve 40 cause piston rod 30 due to the two spline engage and rotate, piston rod 30 in It is to advance because it threadingly engages in housing 10.The rotation of Dose setting member 60 also causes measuring element 110 axially across shifting Its zero position is returned, thus zero-dose butting section stops the mechanism.During distribution, if the power of button 70 in the assignment procedure in Way is removed, then spline interface 43,61 other between drive sleeve 40 and Dose setting member 60 is engaged, to prevent dosage setting Element 60 is rotated freely, and at this moment clutch disc 120 can be re-established to the ratchet mechanism of drive sleeve 40 in drive sleeve 40 It is temporarily unloaded before being engaged with the rotation between the spline of restoring board 150.
Touch feedback during dosage distribution is that flexible cantilever thump the acoustical generator arm 72 by being integrated in button 70 is carried (Fig. 9) for supplying.Flexible cantilever thump acoustical generator arm 72 is diametrically combined with the ratchet structure 66 on Dose setting member 60. During distribution, when Dose setting member 60 rotates and button 70 is connected to housing 10 in steering, structure 66 is sent out with click Sound device arm 72 to interact and produce audible click with the conveying with each incremental dose (dose counting).
When user continues to press button 70, delivered dose is continued by above-mentioned mechanical interaction.If user releases Button 70 is put, then trigger spring 130 makes button 70 return to its spare space via drive sleeve 40 and clutch disc 120, Drive sleeve 40 is constrained in restoring board via clutch teeth 41,151 in steering, and the conveying of dosage stops.
During delivered dose, drive sleeve 40 and Dose setting member 60 rotate together so that in final dose nut There is no relative motion in 50.Therefore, final dose nut 50 is only selecting (and reset) period along the axial direction of drive sleeve 40 Advance.
The conveying that zero-dose butting section stops dosage being returned to upon Dose setting member 60, user can just discharge Button 70, release button 70 will be such that the spline tooth 41,151 of drive sleeve 40 is re-engaged with restoring board 150.Mechanism now turns to To stand-by state.
The mechanism also includes cartridge-holder spring 160, and the cartridge-holder spring 160 acts on the rear table of cartridge case 100 On face (edge), cause its distal direction inclined.This contributes to Dose accuracy, because this ensures that cartridge case 100 always Distad partially, eliminated the tolerances of the length of cartridge case 100 and cartridge case 100 is moved to nearside when pin is assembled on device Dynamic possibility.In an illustrated embodiment, cartridge-holder spring 160 is made up of wavy spring part, but it can also be Any spring assembly.
The spline tooth 41,151 of drive sleeve 40 or restoring board 150 on any one can be inclined so that work as release button When 70, being re-engaged for spline tooth makes drive sleeve 40 somewhat reverse, so as to eliminate Dose setting member 60 to measuring element The engagement of 110 zero-dose backstop butting sections.Which compensates the influence of mechanism intermediate gap (such as being caused due to tolerance), otherwise when Select device to obtain during with post dose, may result in the slight advance of piston rod 30 and distribute medicine is (due to Dose setting member 60 zero-dose backstops no longer controlling organization, but control returns to the spline between drive sleeve 40 and housing 10).
In order that reset, user turns on cartridge-holder 20 first, it is allowed to which trigger spring 130 is by restoring board 150 (and therefore Dose setting member 60) distal direction moves axially (Figure 12 a).The axial movement is enough to disconnect restoring board 150 And the spline 41,151 between drive sleeve 40 and the spline between clutch disc 120 and Dose setting member 60 122,65. Also eliminate some compressions come from trigger spring 130.Meanwhile, the spline tooth on Dose setting member 60 and housing 10 14th, engaged between 62, to lock Dose setting member 60 in steering.If which ensure that selected dosage, Then Dose setting member 60 can not be returned to its zero position by driving spring 90 during the operation that resets.The He of Dose setting member 60 Spline interface 64,71 between button 70 is remained engaged with, so as to prevent button 70 from rotating in the reset state.
Then, can be assembled to new cartridge 100 in cartridge-holder 20 by user, and by supporting member 140 and piston rod 30 It back into the mechanism.When in the gigback of piston rod 30, produced in piston rod 30 due to the hickey of housing 10 Rotation.The rotation of the piston rod 30 causes that drive sleeve 40 is rotated due to the two spline interface, and its effect is to make final dose Nut 50 is inverted towards its original position.
When reset closes to an end, the contact housing 10 of cartridge-holder 20, now, supporting member 140, piston rod 30 and last Dose nut 50 has reached complete reset position.Then, cartridge-holder 20 is pure rotates to latched position, for making restoring board 150 (and therefore making Dose setting member 60) proximal directions are moved, with drive sleeve 40 and clutch disc 120 again spline Engagement.
In present example as described above, button 70 is pressed under the reset state of device will cause drive sleeve 40 And the spline 41,151 between restoring board 150 is re-engaged, so as to prevent any further action from device is resetted, until pressing Untill button 70 is released.
This can be prevented by controlling the relatively rotation place of spline interface so that in the reset state, when dosage sets When determining element 60 and locking onto housing 10 in steering, Dose setting member 60 rotates button 70 so that spline 71 is in the axial direction Can not be moved axially (Figure 13) against housing spline 15, therefore button 70.
Reference：
10 housing 11a, 11b are open (window, hole)
The band of 12 flange shape inwall 13
The spline of 14 spline 15
The piston rod of 20 cartridge-holder 30 (driving screw)
The drive sleeve of 31 external screw thread 40
The hook tooth of 41 tooth 42
The screw thread of 43 spline 44
50 nuts (final dose nut) 60 Dose setting members (digital sleeve, dosage indicator)
The spline of 61 spline 62
The spline of 63 screw thread 64
The ratchet mechanism of 65 tooth 66
The spline of 70 button 71
72 thump the dosage selectors of acoustical generator arm 80
The cartridge case of 90 torsionspring 100
110 measuring elements 111 are open in (window, hole)
The clutch disc of 112 helical structure 120 (clutch element)
The tooth of 121 hook tooth 122
130 clutch springs (trigger spring) 140 supporting members
The spline of 150 restoring boards (reset element) 151
160 cartridge-holder spring I longitudinal axis

Claims (15)

1. a kind of delivery device, the medicament for selecting and distributing multiple user's variable doses, the delivery device Including：
Housing (10)；
Dose (60), it can rotate during dosage setting and dosage are distributed relative to the housing (10)；
Drive member (40), it passes through clutch (120) and is connected to the dose (60)；
Piston rod (30), it is connected to the housing (10) and is connected to the drive member (40),
Characterized in that,
The delivery device also includes：
Cartridge-holder (20), it is removably attached to the housing (10)；
Reset element (150), it is constrained in the Dose setting member (60) in the axial direction；
At least one spring (130), it is acted in the reset element (150) so that if the cartridge-holder (20) Pulled down from the housing (10), then the reset element (150) moves axially to the dosage relative to the housing (10) Setting element (60) is constrained in the housing (10) in steering and allows the drive member (40) relative to the housing (10) position of rotation.
2. delivery device according to claim 1, wherein, if the cartridge-holder (20) be attached to it is described Housing (10), then the cartridge-holder (20) reset element (150) and the Dose setting member (60) is overcome institute The deflection for stating at least one spring (130) moves to the Dose setting member (60) and can be rotated relative to the housing (10) Position.
3. delivery device according to claim 1 and 2, wherein, the reset element (150) is for good and all in steering It is constrained in the housing (10).
4. delivery device according to any one of the preceding claims, wherein, the drive member (40) being capable of phase Moved axially between dose setting position and dosing position for the housing (10), in the dose setting position In, the drive member (40) is constrained in the housing (10) through the reset element (150) in steering, in the dosage point In with position, the drive member (40) can rotate relative to the reset element (150) and the housing (10).
5. delivery device according to claim 4, wherein, at least one spring (130) causes the driving Component (40) is partial to enter its dose setting position.
6. delivery device according to any one of the preceding claims, wherein, the housing (10) is including inwardly prominent The wall or web (12) for going out, the inwardly projecting wall or web (12) with central opening and at least one another opening, its In, one in the cartridge-holder (20) and the reset element (150) includes extending through another opening extremely A few axially extending finger.
7. delivery device according to claim 6, wherein, the inwardly projecting wall or web (12) include interior spiral shell Line, and wherein, the piston rod (30) is constrained in the drive member (40) and including engaging the interior spiral shell in steering The external screw thread (31) of line.
8. the delivery device according to claim 6 or 7, also including at least one cartridge-holder spring (160), institute At least one cartridge-holder spring (160) is stated in the axial direction between the cartridge-holder (20) and the inwardly projecting wall Or between web (12).
9. delivery device according to any one of the preceding claims, also including between the housing (10) and described Driving spring (90) between Dose setting member (60), preferably torsionspring (90).
10. delivery device according to any one of the preceding claims, is additionally included in radially between the housing (10) measuring element (110) and between the Dose setting member (60), wherein, the measuring element (110) can be relative Moved axially in the housing (10) and be threadedly engaged with the Dose setting member (60).
11. delivery devices according to claim 10, wherein, the housing (10) including at least one hole (11a, 11b), the measuring element (110) includes at least one hole (111), and the Dose setting member (60) is wrapped on its outer surface Mark is included, and wherein, during dosage setting and dosage are distributed, at least one of described mark can be by the metering The hole (111) of element (110) and the hole (11b) of the housing (10) are seen.
12. delivery device according to claim 10 or 11, wherein, the measuring element (110) is including minimizing agent Amount rotation backstop and maximum dose rotation backstop, and the Dose setting member is including minimum dose rotation pairing backstop and most Heavy dose rotation pairing backstop.
13. delivery devices according to any one of the preceding claims, wherein, the slip-clutch (42,121) The first lap clutch teeth (42) being included in the drive member (40) and the second circle clutch in clutch disc (120) Tooth (121), the slip-clutch (42,121) is constrained in the dosage during dosage setting and dosage are distributed in steering Setting element (60).
14. delivery devices according to claim 13, wherein, at least one spring (130) causes the drive Dynamic component (40) is partial to be formed against and wherein, if the cartridge-holder (20) quilt with the clutch disc (120) Pulled down from the housing (10), then at least one spring (130) causes the Dose setting member (60) to be partial to relatively The clutch disc (120) enters the axle that the clutch disc (120) and the Dose setting member (60) disconnect in steering To position.
15. delivery devices according to any one of the preceding claims, also including the cartridge case (100) of receiving medicament.
CN201580054519.0A 2014-10-09 2015-10-09 Medicament injection device with a reset mechanism allowing retraction of the piston rod when changing a cartridge Active CN106794307B (en)

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PCT/EP2015/073443 WO2016055635A1 (en) 2014-10-09 2015-10-09 Drug injection device with resettable mechanism allowing piston rod retraction upon drug cartridge change

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US20170304551A1 (en) 2017-10-26
TR201819651T4 (en) 2019-01-21
EP3204075A1 (en) 2017-08-16
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WO2016055635A1 (en) 2016-04-14
EP3204075B1 (en) 2018-09-26

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